Sue Desmond-Hellmann, AP Images

Sue Desmond-Hell­mann says it's time for her to leave the Gates Foun­da­tion. Strat­e­gy chief Mark Suz­man will now take the helm

Su­san Desmond-Hell­mann, the long­time re­searcher and ex­ec­u­tive who helped lead Genen­tech to de­vel­op the first gene-tar­get­ed can­cer ther­a­pies, is step­ping down af­ter 5 years as CEO of the Bill & Melin­da Gates Foun­da­tion.

Step­ping down as CEO of@Gates­Foun­da­tion is, with­out a doubt, the tough­est de­ci­sion of my ca­reer,” she wrote in the first of a se­ries of tweets an­nounc­ing and re­flect­ing on her de­par­ture. “But one of my mantras is ‘take your own pulse first.’ Over the last few months, I’ve done just that and con­clud­ed that I need to slow down.”

Mark Suz­man

Mark Suz­man, the foun­da­tion’s pres­i­dent of Glob­al Pol­i­cy & Ad­vo­ca­cy and chief strat­e­gy of­fi­cer, will now take over as the new CEO. Suz­man joined the foun­da­tion 12 years ago and takes the new role of­fi­cial­ly on Feb­ru­ary 1, 2020.

Desmond-Hell­mann was named CEO of the mas­sive char­i­ty in 2013, af­ter years at the top of Genen­tech and a stint as the first woman chan­cel­lor of the Uni­ver­si­ty of Cal­i­for­nia San Fran­cis­co. She was the first physi­cian to lead the foun­da­tion and dur­ing her tenure launched what was billed as the first non­prof­it biotech, the Gates Med­ical Re­search In­sti­tute, a move she re­called as one of her top achieve­ments.

Re­cent­ly, the long­time re­searcher cut down on work out­side the foun­da­tion and said to­day she was leav­ing to fo­cus on her­self and her fam­i­ly.

Desmond-Hell­mann got her start in med­i­cine as a kid, hang­ing around and some­times book­keep­ing at the drug­store her par­ents owned in Reno, Neva­da. In lat­er years, she talked about how watch­ing her fa­ther in­ter­act kind­ly with the peo­ple who came in made her want to be­come a doc­tor. Af­ter she grad­u­at­ed from the Uni­ver­si­ty of Neva­da, she took an in­tern job at UCSF in 1982, her for­ma­tive years as a physi­cian spent at the be­gin­ning and cen­ter of the AIDS/HIV cri­sis. Af­ter sev­er­al years work­ing on the virus and Ka­posi’s sar­co­ma, she and her hus­band — Nicholas Hell­mann, al­so a young UCSF doc­tor — moved to Ugan­da to do sim­i­lar work.

“We were ap­proached by the Rock­e­feller Foun­da­tion to study het­ero­sex­u­al HIV trans­mis­sion in Africa, so my hus­band Nick and I sold our Hon­da Civics, sub­let our apart­ment, and hopped on a plane,” she re­called to Reuters in Ju­ly. “We were ex­treme­ly iso­lat­ed. When we came back from Ugan­da, we nev­er com­plained about any­thing ever again.”

She fell in­to drug de­vel­op­ment two years af­ter they re­turned to Nicholas’ home state of Ken­tucky, when they both took po­si­tions at Bris­tol-My­ers Squibb in Con­necti­cut in 1993. She worked on Tax­ol, a chemother­a­py drug orig­i­nal­ly de­rived from Pa­cif­ic yew bark and first FDA-ap­proved short­ly be­fore her ar­rival.

“It was like I had been train­ing my whole life for that job,” Desmond-Hell­mann told the New York Times in 2011.

At the time, Genen­tech hadn’t de­vel­oped any can­cer drugs. The lega­cy biotech brought Desmond-Hell­mann back to San Fran­cis­co in 1995 to help build that pipeline and pro­mot­ed her to chief med­ical of­fi­cer the fol­low­ing year.

Arthur Levin­son, the CEO of Genen­tech dur­ing her tenure, de­scribed her to the New York Times as a shrewd ex­ec­u­tive, who was able to use her on­col­o­gy and sta­tis­ti­cal back­ground to choose the best drugs — and was al­so able to tell re­searchers when their projects weren’t be­ing cho­sen.

“She’s a very nice per­son, so this did not come nat­u­ral­ly to her,” Levin­son said. “But she got it quick­ly. She be­came a tough leader, tough in a pos­i­tive sense. She was will­ing to make tough calls with­out much dif­fi­cul­ty.”

Over 14 years at Genen­tech, she over­saw the de­vel­op­ment of Avastin and Her­ceptin, the first gene-tar­get­ed can­cer ther­a­pies.

She left the com­pa­ny when it was bought out by Roche in 2009, leav­ing as head of prod­uct de­vel­op­ment, and soon went on to be­come chan­cel­lor of UCSF (where there was a brief con­tro­ver­sy over her to­bac­co in­vest­ments, which she im­me­di­ate­ly sold off.). She joined the Gates Foun­da­tion in 2014.

As CEO she over­saw a bevy of pub­lic health pro­grams and, in 2018, the launch of the Gates Med­ical Re­search In­sti­tute in Cam­bridge, MA, lur­ing ex­ec­u­tives from No­var­tis and Mer­ck and oth­er top biotech firms to fill out the lead­er­ship team.

The in­sti­tute launched with a bud­get of $100 mil­lion and tar­gets the Gates Foun­da­tion had long pur­sued: malar­ia, tu­ber­cu­lo­sis, and di­ar­rheal dis­eases. The idea was to help di­rect­ly de­vel­op drugs that the mar­ket wasn’t in­cen­tiviz­ing, in­clud­ing a malar­i­al vac­cine. Their first big project is test­ing if a boost­er shot of Bacil­lus Cal­mette-Guérin, the tu­ber­cu­lo­sis vac­cine al­ready giv­en to in­fants, could help im­prove im­mu­ni­ty for ado­les­cents.

“What keeps me awake is we have all this cap­i­tal, we have all this op­por­tu­ni­ty and we bet­ter get some­thing done,” Desmond-Hell­mann told Forbes last year. “We bet­ter do some good in the world, or I will not feel good about lead­ing in the Gates Foun­da­tion.”

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Gilead claims Tru­va­da patents in HHS’ com­plaint are in­valid

Back in November, the Department of Health and Human Services took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP).

But on Thursday, Gilead filed its own retort, making clear that it does not believe it has infringed on the Centers for Disease Control and Prevention’s (CDC) Truvada patents because they are invalid.

Aymeric Le Chatelier, Ipsen

A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back -- this time flunk­ing fu­til­i­ty test -- as FDA hold re­mains in ef­fect for Ipsen

David Meek

At the time Ipsen stepped up last year with more than a billion dollars in cash to buy Clementia and a late-stage program for a rare bone disease that afflicts children, then CEO David Meek was confident that he had put the French biotech on a short path to a mid-2020 launch.

Instead of prepping a launch, though, the company was hit with a hold on the FDA’s concerns that a therapy designed to prevent overgrowth of bone for cases of fibrodysplasia ossificans progressiva might actually stunt children’s growth. So they ordered a halt to any treatments for kids 14 and under. Meek left soon after to run a startup in Boston. And today the Paris-based biotech is grappling with the independent monitoring committee’s decision that their Phase III had failed a futility test.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,500+ biopharma pros reading Endpoints daily — and it's free.

Roche's check­point play­er Tecen­triq flops in an­oth­er blad­der can­cer sub­set

Just weeks after Merck’s star checkpoint inhibitor Keytruda secured FDA approval for a subset of bladder cancer patients, Swiss competitor Roche’s Tecentriq has failed in a pivotal bladder cancer study.

The 809-patient trial — IMvigor010 — tested the PD-L1 drug in patients with muscle-invasive urothelial cancer (MIUC) who had undergone surgery, and were at high risk for recurrence.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,500+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,500+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,500+ biopharma pros reading Endpoints daily — and it's free.

Gilead dusts off a failed Ebo­la drug as coro­n­avirus spreads; Ex­elix­is boasts pos­i­tive Ph I/II da­ta

→ Less than a year ago Gilead’s antiviral remdesivir failed to make the cut as investigators considered a raft of potential drugs that could be used against an Ebola outbreak. But it may gain a new mission with the outbreak of the coronavirus in China, which is popping up now around the world.

Gilead put out a statement saying that they’re now in discussions with health officials in the US and China about testing their NUC against the virus. It’s the latest in a growing lineup of biopharma companies that are marshaling R&D forces to see if they can come up with a vaccine or therapy to blunt the spread of the virus, which has now sickened hundreds, killed at least 17 people and led the Chinese government to start quarantining cities.

Alex Karnal (Deerfield)

Deer­field vaults to the top of cell and gene ther­a­py CD­MO game with $1.1B fa­cil­i­ty at Philadel­phi­a's newest bio­phar­ma hub

Back at the beginning of 2015, Deerfield Management co-led a $10 million Series C for a private gene therapy startup, reshaping the company and bringing in new leaders to pave way for an IPO just a year later.

Fast forward four more years and the startup, AveXis, is now a subsidiary of Novartis marketing the second-ever gene therapy to be approved in the US.

For its part, Deerfield has also grown more comfortable and ambitious about the nascent field. And the investment firm is now putting down its biggest bet yet: a $1.1 billion contract development and manufacturing facility to produce everything one needs for cell and gene therapy — faster and better than how it’s currently done.